FlexiOss Dent

New bone defect filler designated for regenerative medicine

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Description

About the product

FlexiOss® Dent is a modern implantable biomaterial of third generation:    Biphasic (hydroxyapatitepolymeric), bioactive, supporting the regeneration of bone tissue and a potential drug carrier.

The combination of two main compounds of composite was performed by polymer gelling into the structure of irreversible, collagen-like triple helix – the conformation which does not evoke the appearance of local inflammation processes and enables the entrapment of HAP granulate.

After implantation undergoes an integration with patient’s bone tissue in beneficial manner and is slowly remodelled and replaced with natural bone tissue. This eliminates the necessity of reoperation in order to remove the implanted biomaterial. Thus, the patient’s stress and pain is limited to the minimum.

Available in 3 sizes: 1 cm3 cm and 5 cm.

Properties

  1. flexible after soaking (plastic and bendable)
  2. bio-compatible with natural bone tissue
  3. mechanical parameters similar to those of cancellous bone
  4. actively supports bones reconstruction process
  5. absorbs blood and medicine solutions
  6. positively influences the bone tissue regeneration process
  7. ionic reactive / bioactive
  8. non-toxic material
  9. can be used for defects of
  10. up to 7 cm in length
  11. non-animal material (lowering risk of pathogens transmission and appearance of allergic reactions)
  12. easy to carry and store

Surgical handiness

Surgical handiness, which allows to fit it during the operation to the shape of individual bone defects by cutting or bending.

Can be milled

In a dry state, FlexiOss®Dent can be milled which enables the personalization of the composite implant.

Faster ossification

High specific surface area (due to the high microporosity of granules), high ionic reactivity (adsorption of calcium and phosphate ions from surroundings liquid which allows to increase the rate of mineralization within the implantation site and increase the rate of new bone tissue formation).

Minimizes the risk of viruses and prions contamination

Application of carbohydrate polymer to produce FlexiOss® composite minimizes the risk of viruses and prions contamination. Curdlan undegoes gelling, forming the structure of irreversible, collagen-like triple helix – the conformation which is neutral for macrophages and does not evoke the appearance of local inflammation.

High soaking capacity

FlexiOss®Dent exhibit high soaking capacity. This simplify the nutrient supply to the biomaterial within the implantation site and removal of metabolic degradation products, thus increasing the rate of bone tissue regeneration. Before the implantation, it can be soaked in solution of antibacterial drugs, thus minimizing the risk of perioperative infections and implant rejection. Due to its properties, it can be also soaked in, for example, platelet rich plasma (PRP) and solution of growth factors (commercial or isolated from patient’s blood). Thus, the biomaterial may resemble (in its properties) very expensive bone-substitutes containing BMP-2-type growth factors.
Can be easily stored and transportedCan be easily stored and transported.

Studies

The biomaterial was subjected to preliminary preclinical evaluation on patients of Animal Surgery Clinic of Veterinary Medicine Faculty, University of Life Sciences in Lublin, Poland. The bone replacement material has been used for filling bone defects resulting from the teeth extraction and for treatment of oronasal fistulae in dogs and cats.

The biomaterial was subjected to preliminary preclinical evaluation on patients of Animal Surgery Clinic of Veterinary Medicine Faculty, University of Life Sciences in Lublin, Poland. The bone replacement material has been used for filling bone defects resulting from the teeth extraction and for treatment of oronasal fistulae in dogs and cats.

Publications

  1. Borkowski L., Kiernicka M., Belcarz A., Pałka K., Hajnos M., Ginalska G. Unexpected reaction of new HAp/glucan composite to environmental acidification: Defect or advantage? Biomed. Mater. Res. B Appl. Biomater. 2017, 1 05(5), 1178-1190.
  2. Borkowski L., Lübek T., Jojczuk M., Nogalski A., Belcarz A., Palka K., Hajnos M., Ginalska G. Behavior of new hydroxyapatite/glucan composite in human serum, Journal of Biomedical Materials Research Part B: Applied Biomaterials’ 2018 Feb 6 [Epub ahead of print].
  3. Borkowski L., Sroka-Bartnicka A., Drączkowski P., Ptak A., Zięba E., Ślósarczyk A., Ginalska G. The comparison study of bioactivity between composites containing synthetic non-substituted and carbonate-substituted hydroxyapatite. Mater. Sci. Eng. C Mater. Biol. Appl. 2016, 62, 260-267.
  4. Belcarz A., Zima A., Ginalska G. Biphasic made of antibacterial action of aminoglycoside antibiotics- loaded elastic hydroxyapatite-glucan composite. Int. J. Pharm. 2013, 454, 285-295.
  5. Belcarz A., Ginalska G., Pycka T., Zima A., Ślósarczyk A., Polkowska I., Paszkiewicz Z., Piekarczyk W. Application of β-1,3-glucan in production of ceramics-based elastic composite for bone repair. Centr. Eur. J. Biol. 2013, 8, 534-548.